Suspended

Nab-Paclitaxel and Radiation for Unresectable Pancreatic Cancer

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Study Aim

This study aims to evaluate the safety and side effects of combining Nab-Paclitaxel with radiation in people with pancreatic cancer that cannot be surgically removed.

What is being tested

Abraxane

+ Radiotherapy

DrugRadiation
Who is being recruted

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2014
See protocol details

Summary

Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2014

Actual date on which the first participant was enrolled.

This clinical trial aims to find better treatment methods for individuals with pancreatic cancer that cannot be surgically removed or is on the borderline of being removable. The study looks to improve how well local treatments work in controlling the cancer and boosting survival rates by using a combination of a chemotherapy drug called nab-paclitaxel and increased doses of radiation therapy. The trial is significant because it explores using nab-paclitaxel’s unique properties to enhance the effectiveness of radiation, offering hope for improved management of this challenging cancer type. Participants in the study will receive nab-paclitaxel alongside radiation therapy to see how the combined treatment affects the cancer. In the beginning, the dose of nab-paclitaxel will be increased while radiation remains at a standard level to find the maximum tolerated dose. Later, the treatment will include the addition of a drug called paricalcitol. The study uses advanced radiation technologies like IMRT or protons to target the cancer effectively while protecting nearby healthy tissues. Patients may also receive standard chemotherapy before or after this combined treatment. The study closely monitors for any adverse effects to ensure safety and gather insights on the treatment’s impact.

Official TitleA Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer
NCT02207465
Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
ECOG performance status of ≤ 1.

Adequate organ function defined as follows: absolute neutrophil count of ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 2 mg/dl, total bilirubin ≤ 3, (with relief of biliary obstruction if present (PTC tube or endobiliary stent) and AST \< 5 times the upper limit of normal.

Pathologically confirmed adenocarcinoma of the pancreas.

Unresectable disease or borderline resectable disease assessed by a multidisciplinary panel of pancreas surgeon, medical and radiation oncologist, and a radiologist. Criteria defining unresectable and borderline resectable patients will be based on the NCCN Guidelines (v 1.2014): Unresectable Greater than 180 degrees of SMA encasement Any celiac abutment Unreconstructible SMV/portal occlusion Aortic invasion or encasement Nodal metastases beyond the field of resection Borderline resectable Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen Encasement of the SMV/portal vein but without encasement of the nearby arteries Short-segment venous occlusion resulting from either tumor thrombus or encasement with suitable proximal and distal vessel for reconstruction/grafting. Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to celiac axis Tumor abutment to SMA but not to exceed greater than 180 degrees of circumferential vessel wall

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7 exclusion criteria prevent from participating
Distant metastatic disease.

Prior systemic therapy for pancreatic cancer.

Prior history of abdominal radiation therapy.

Prior or simultaneous malignancy within the past 2 years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ, thyroid carcinoma, or low-risk prostate cancer). In-situ carcinoma is allowed.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Determine if it is safe or not (via occurrence of dose limiting toxicities) for patients to receive both Abraxane and radiation therapy.

Group II

Experimental
Determine the maximum dose of Abraxane that is allowable and safe for patients receiving both Abraxane and radiation therapy.

Group III

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, United StatesOpen Abramson Cancer Center of the University of Pennsylvania in Google Maps
Suspended

Chester County Hospital

West Chester, United States
Suspended2 Study Centers